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It’s well-known that the National Institutes of Health (NIH) offers billions of dollars in grants to US academic research facilities. What’s less well-known is that each year, hundreds of new inventions are produced in the laboratories of NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), and these inventions are licensed out to private companies in the US and internationally for further research and development, with the hopes of bringing new products to market.

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Clinical-stage biopharma Protalex, Inc. on Thursday said it has been awarded a $403,000 grant from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for immune thrombocytopenia (ITP).

RAPS will honor two groups of exemplary regulatory leaders next month at its annual Regulatory Convergence conference. Four outstanding individuals will be the inaugural recipients of the Founder’s Award, the profession’s highest honor. Three honorees will be the first-ever recipients of the Community Leadership Award.

FDA Extends Use Dates for Pfizer Injectables to Ease Shortage

The US Food and Drug Administration (FDA) on Thursday said it is extending the use dates of multiple lots of injectable drugs made by Pfizer subsidiary Hospira by six months to a year in response to an ongoing shortage of the drugs.

In recent months Hospira has suffered a number of setbacks related to its injectables, and has issued recalls for multiple products due to the presence of particulate matter and potential lack of sterility assurance. FDA also warned Hospira's Kansas site in February for failing to adequately investigate complaints about particulate matter and other good manufacturing practice (GMP) issues.

In a letter to its customers last month, Pfizer attributed the shortage of its injectables, which include atropine sulfate, dextrose 50% and epinephrine, to "manufacturing, distribution and third party delays."

For the time being, FDA says it is extending the use date for specific lots of Pfizer's atropine sulfate for six or 12 months, dextrose 50% for 12 months and epinephrine for nine months. However, FDA says it is not asking for those lots to be relabeled with new use dates, and says the drugs should be disposed of according to their original use dates if replacement product becomes available.

In the letter, Pfizer says it has already begun taking steps to address the shortages, including prioritizing the production of medically necessary drugs, increasing production and qualifying third-party suppliers for the products. The company also notes that it expects a "full recovery" for nearly all of products in shortage by the end of 2017.

FDA says it is working closely with Pfizer to resolve the shortages and address their root causes. The agency also says it is exploring other options to ease the shortage, including expediting its review of applications for the affected products or temporary importation from other countries.

Ahead of its summer recess, the US Senate on Thursday followed its House counterparts and passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years. View More